Model: CONN-HX1
DI: 28051160301564
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
7b2fb5de-0362-4886-8ed9-4e70d9dc1b66
Distribution Status:
In Commercial Distribution
DUNS Number:
436188505
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
28051160301564
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 11973
Name: Cardiopulmonary bypass system heat exchanger, reusable
Definition:
A device consisting of a heat exchanging system intended to be used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device for the purposes of cardiopulmonary bypass intervention or treatment. This device will typically be a module of a cardiopulmonary bypass system whereby it receives thermal transfer fluid at a specific temperature from a system heating/cooling unit. This is a reusable device.
FDA Product Codes
KRI
Accessory Equipment, Cardiopulmonary Bypass